This is where your work makes a difference.
At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job—you will find purpose and pride.
Drive Scientific Excellence in Patient Safety
Are you ready to make a meaningful impact in the field of Extractables and Leachables (E&L)?
At Baxter, we are committed to advancing patient safety through rigorous science and innovation. We are seeking an experienced Study Director – E&L to lead high‑impact studies supporting medical devices and drug product packaging used around the world.
Based in Braine‑l’Alleud, this role offers the opportunity to collaborate with leading scientists, influence regulatory strategy, and shape the future of E&L science in a dynamic, global environment.
Your Role
As a Study Director, you will lead the design, execution, and scientific oversight of E&L studies, ensuring alignment with global regulatory and industry standards such as ISO 10993‑18 and USP <1663> / <1664>.
You will develop robust E&L strategies that balance regulatory compliance, scientific rigor, and innovative product development, while acting as a key scientific interface across multiple functions.
Study Design & Scientific Leadership
Design, direct, and oversee extractables and leachables studies for medical devices and drug product packaging.
Author and review study protocols, reports, and technical documentation, incorporating input from subject matter experts.
Lead method development, validation, and transfer activities in collaboration with internal teams and external laboratories.
Strategic E&L Development
Develop E&L strategies aligned with regulatory pathways, biocompatibility requirements, and customer expectations.
Ensure scientific justification of study designs and results to support innovative and compliant products.
Data Interpretation & Risk Assessment
Review and interpret E&L data, identifying trends and correlations with materials of construction.
Drive the structural identification of extractables and leachables.
Collaborate closely with Biocompatibility and Toxicology teams on toxicological risk assessments.
Cross‑Functional & Regulatory Engagement
Work cross‑functionally with Chemistry, Regulatory Affairs, Toxicology, Manufacturing, Program Management, and external partners.
Participate in regulatory interactions, including submissions, pre‑submission meetings, and responses to authority questions.
Lead or support scientific investigations related to E&L findings.
Quality & Compliance
Maintain a strong understanding of Quality System Regulations.
Ensure compliance across study execution, data integrity, and reporting.
Education & Experience
Bachelor’s degree in a scientific discipline (ideally Chemistry or Biochemistry) with 10+ years of relevant experience, or
Master’s degree with 5–7 years, or
PhD with 3+ years of experience in a related field.
Technical Expertise
Demonstrated experience in Extractables & Leachables studies.
Strong background in analytical method development and validation.
Solid knowledge of analytical techniques such as LC/MS/UV, GC/MS/FID, and ICP‑MS.
Experience with chemical characterization standards for medical devices and container closure systems.
Regulatory Knowledge
Familiarity with global E&L regulatory expectations, particularly for medical devices and drug product packaging.
Professional Skills
Strong scientific judgment and critical thinking.
Ability to lead complex studies with autonomy and rigor.
Excellent communication and collaboration skills.
Comfortable working in cross‑functional, multicultural teams.
Contribute directly to patient safety and product quality worldwide.
Lead scientifically complex, high‑visibility studies with global impact.
Work alongside recognized experts in analytical chemistry and biocompatibility.
Thrive in an environment that values innovation, collaboration, and scientific integrity.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.
What We Do
Every day, millions of patients, caregivers and providers around the world rely on Baxter’s leading portfolio of diagnostic, critical care, nutrition, kidney care, hospital and surgical products and solutions. For 90 years, we’ve been making an impact at the critical intersection where innovations that save and sustain lives meet the healthcare providers who make it happen. With products, therapies and digital health solutions available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. We welcome Hillrom to Baxter, where we are uniting to advance patient care worldwide. We’re building on the strengths of two historically innovative and socially responsible companies that will better serve our patients, customers and communities.
